Hey guys, I’m new here (this is just my second post) and I was diagnosed with PSC in March. My new hepatologist is with the transplant center with UAB in Birmingham. I’ve just had one appointment with him so far and he seems very knowledgeable about PSC and the various studies on treatments out there. He says he never prescribes Urso for PSC because studies have shown that in low dosages it has no effect and in higher dosages it can actually lead to more negative outcomes. Has anyone else heard this from their doc?
Yes. I have.
I have heard that high-dose URSO can cause adverse effects. I was on 1200 mg of URSO daily for 4 years without any issues to speak of. I did have to rearrange at times the times of day I took the medication but other than that it was beneficial to helping thin the bile so it would flow better.
I’ve been on Urso 500mg twice a day for 16 years now and I haven’t had any problems. My liver enzymes have gone up slightly every year, but they’re still lower than when I was diagnosed. Thanks for sharing this information! I’m going to look further into it.
I have heard that as well with ursodiol, but I do not know the reasoning. My dosage of ursodiol was recently reduced and I’m actually going to get a second opinion to specifically discuss urso and dosing ( amongst other things).
Sounds like you have a great doc at a reputable transplant center. I really like my current doctor, but I think in a rare disease like psc (where there is still so much unknown), it’s important that we are as informed as possible in order to be our own best advocate. And for me that Sometimes means getting a second opinion. I’ve been curious about this urso question for a while and will post If I find any explanation.
The following is copy and pasted from the medical database, UpToDate:
High-dose UDCA — Pilot studies suggested that UDCA given in higher-than-standard doses (20 to 30 rather than 13 to 15 mg/kg per day) may increase the benefit [24-27]. However, a placebo-controlled trial involving 150 patients was stopped early because patients randomly assigned to UDCA at doses of 28 to 30 mg/kg per day were significantly more likely to reach the primary endpoint of death, need for liver transplant, or development of varices . A follow-up study found that the increased risk of adverse events with high-dose UDCA was limited to patients with early histologic stage disease or with normal total bilirubin levels . The reasons for the unexpected outcome are unclear, but based upon these data, high-dose UDCA should be avoided in patients with PSC.
Below are the summarized conclusions of the studies they cited to summarize the above recommendations:
1st study: High-dose ursodeoxycholic acid as a therapy for patients with primary sclerosing cholangitis. ( 2001) (referenced as 24-27)
CONCLUSIONS: UDCA at a dose of 25-30 mg/kg per day may be of benefit for patients with PSC, and this regimen deserves further evaluation in a long-term, randomized, placebo-controlled trial.
2nd study: High-dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis. 2009 (referenced above as 28)
CONCLUSION: Long-term, high-dose UDCA therapy is associated with improvement in serum liver tests in PSC but does not improve survival and was associated with higher rates of serious adverse events
3rd study: High-dose ursodeoxycholic acid increases risk of adverse outcomes in patients with early stage primary sclerosing cholangitis (2011)
CONCLUSION: The increased risk of adverse events with UDCA treatment when compared with placebo is only apparent in patients with early histological stage disease or normal total bilirubin.
Hope this is somewhat helpful